{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-30",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Aveeno Eczema Therapy Daily Moisturizing Colloidal Oatmeal DISTEARYLDIMONIUM CHLORIDE STEARETH-20 CERAMIDE NP SODIUM CHLORIDE DIMETHICONE BENZALKONIUM CHLORIDE OAT WATER OATMEAL OATMEAL GLYCERIN PANTHENOL PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL OAT KERNEL OIL"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558"
      ],
      "active_ingredient": [
        "Active Ingredient Colloidal Oatmeal 1%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema"
      ],
      "warnings": [
        "Warnings For external use only. When using this product do not get into eyes Stop use and ask a doctor if condition worsens •symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens •symptoms last more than 7 days or clear up and occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions apply as needed"
      ],
      "storage_and_handling": [
        "Other Information for use on mild to moderate eczema or as directed by a physician store at room temperature."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Sodium Chloride, Avena Sativa (Oat) Kernel Extract"
      ],
      "questions": [
        "Questions? 866-428-3366 ; Outside US, dial collect 215-273-8755 www.aveeno.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 354 mL Bottle Aveeno ® Eczema Therapy DAILY MOISTURIZING CREAM Colloidal Oatmeal Skin Protectant Relieves Eczema-Prone Skin Clinically shown to soothe dry, itchy, irritated skin due to eczema STEROID FREE FRAGRANCE FREE ACCEPTED e National Eczema Association DERMATOLOGIST RECOMMENDED BRAND COLLOIDAL OATMEAL & CERAMIDE 12 fl oz (354mL) Aveeno_01"
      ],
      "set_id": "e4c85780-7cb2-b55c-e053-2995a90a0314",
      "id": "216bde51-8922-d835-e063-6394a90a20e0",
      "effective_time": "20241105",
      "version": "4",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Aveeno Eczema Therapy Daily Moisturizing"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Kenvue Brands LLC"
        ],
        "product_ndc": [
          "69968-0774"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "240651"
        ],
        "spl_id": [
          "216bde51-8922-d835-e063-6394a90a20e0"
        ],
        "spl_set_id": [
          "e4c85780-7cb2-b55c-e053-2995a90a0314"
        ],
        "package_ndc": [
          "69968-0774-2"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0381371156658"
        ],
        "nui": [
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "N0000185016"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]"
        ],
        "unii": [
          "8PI54V663Y"
        ]
      }
    }
  ]
}